Clinical trial · no report yet · Phase 1
IDRX-42-001
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
- NCT05489237 ↗
- Active, not recruiting
- IDRX, Inc., a wholly owned subsidiary of GSK, LLC
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| Bluesky threads | 6 | |
| YouTube | 1 | |
| Podcasts | 1 | |
| X threads | 1 |
The trial
ClinicalTrials.gov- Official title
- A FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST)
- Phase
- Phase 1
- Status
- Active, not recruiting
- Conditions
- Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumor (GIST); Digestive System Disease; Gastrointestinal Diseases; Metastatic Cancer
- Interventions
- IDRX-42
- Arms
- Dose Escalation (Phase I) · Experimental
- (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy · Experimental
- (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy · Experimental
- (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve · Experimental
- (Phase 1b): Cohort 4 · Experimental
- Enrollment
- 276
- Primary outcomes
- Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
- Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
- Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42
- Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysis
- Phase 1b-Number of participants with TEAEs and with laboratory test results
- Phase 1b - Objective Response Rate (ORR) mRESIST v1.1
- Phase 1b - C-QTcF sub-study: QTcF - concentration response analysis
- Sponsor
- IDRX, Inc., a wholly owned subsidiary of GSK, LLC
- Start
- Aug 3, 2022
- Primary completion
- Mar 10, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05489237 · updated Oct 5, 2026